Assistant Director, Clinical Trials Quality Assurance Program
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Job Location:
Chapel Hill, NC - USA
Monthly Salary:
Not Disclosed
Posted on:
30+ days ago
Vacancies:
1 Vacancy
Job Summary
Position Summary
INTERNAL ONLY : Internal posting for permanent time-limited and layoff priority employees of UNC -Chapel Hill only. This position may be eligible for a hybrid work arrangement that may include a partially remote work location consistent with System Office policy. UNC Chapel Hill employees are generally required to reside within a reasonable commuting distance of their assigned duty station. The Assistant Director for Clinical Trials Quality Assurance ( CTQA ) Program will be responsible for designing and maintaining a program to audit clinical trial studies to ensure that they are being conducted pursuant to the terms and conditions of their Institutional Review Board approval the sponsor or grant agreement governing laws and regulations good clinical practice and UNC -CH policies and procedures. The position will report to the Director of the Clinical Research Compliance Office ( CRCO ) but will be expected to have strong collegial relationships with administrators in the Office of Human Research Ethics ( OHRE ) the Office of Sponsored Research and the Office of Research Compliance among others. A review methodology will be adopted that will establish goals and objectives such as the target number of reviews that will be carried out over the course of a addition the reviewer must be available to lead directed reviews that may be undertaken as a result of allegations of noncompliance or misconduct or in preparation for an examination inspection by a regulatory agent. The successful candidate will demonstrate a mastery of regulations promulgated by the Office of Human Research Protections the Food and Drug Administration the Public Health Service and National Institutes of Health and others.
Required Qualifications Competencies And Experience
INTERNAL ONLY : Internal posting for permanent time-limited and layoff priority employees of UNC -Chapel Hill only. * Substantial experience with clinical research administration * Experience in university clinical research administration or closely related relevant experience * Demonstrated familiarity with FDA and OHRP guidelines and regulations as well as have knowledge of Good Clinical Practice ( GCP ) * Demonstrated ability to work effectively with faculty staff administrators and the business community
Preferred Qualifications Competencies And Experience
* Masters degree in science or health/life sciences * 5 years or more of university clinical research administration or closely related relevant experience * Demonstrated strong communication skills * ACRP or SOCRA certification
INTERNAL ONLY : Internal posting for permanent time-limited and layoff priority employees of UNC -Chapel Hill only. This position may be eligible for a hybrid work arrangement that may include a partially remote work location consistent with System Office policy. UNC Chapel Hill employees are generally required to reside within a reasonable commuting distance of their assigned duty station. The Assistant Director for Clinical Trials Quality Assurance ( CTQA ) Program will be responsible for designing and maintaining a program to audit clinical trial studies to ensure that they are being conducted pursuant to the terms and conditions of their Institutional Review Board approval the sponsor or grant agreement governing laws and regulations good clinical practice and UNC -CH policies and procedures. The position will report to the Director of the Clinical Research Compliance Office ( CRCO ) but will be expected to have strong collegial relationships with administrators in the Office of Human Research Ethics ( OHRE ) the Office of Sponsored Research and the Office of Research Compliance among others. A review methodology will be adopted that will establish goals and objectives such as the target number of reviews that will be carried out over the course of a addition the reviewer must be available to lead directed reviews that may be undertaken as a result of allegations of noncompliance or misconduct or in preparation for an examination inspection by a regulatory agent. The successful candidate will demonstrate a mastery of regulations promulgated by the Office of Human Research Protections the Food and Drug Administration the Public Health Service and National Institutes of Health and others.
Required Qualifications Competencies And Experience
INTERNAL ONLY : Internal posting for permanent time-limited and layoff priority employees of UNC -Chapel Hill only. * Substantial experience with clinical research administration * Experience in university clinical research administration or closely related relevant experience * Demonstrated familiarity with FDA and OHRP guidelines and regulations as well as have knowledge of Good Clinical Practice ( GCP ) * Demonstrated ability to work effectively with faculty staff administrators and the business community
Preferred Qualifications Competencies And Experience
* Masters degree in science or health/life sciences * 5 years or more of university clinical research administration or closely related relevant experience * Demonstrated strong communication skills * ACRP or SOCRA certification
Required Experience:
Staff IC
Key Skills
- Quality Assurance
- FDA Regulations
- ISO 9001
- Root cause Analysis
- Biotechnology
- Clinical Trials
- Quality Systems
- Food Processing
- Quality Control
- Quality Management
- cGMP
- HACCP
About Company
The University of North Carolina at Chapel Hill, the nation’s first public university, is a global higher education leader known for innovative teaching, research and public service. A member of the prestigious Association of American Universities, Carolina regularly ranks as the best ... View more
